A vaccine or a placebo?
In the NIC Gamalei told when it is possible to find out whether the volunteer received a placebo or a "Satellite V"
A volunteer participating in post-registration studies of the Sputnik V vaccine will be able to find out whether he received the vaccine or a placebo only after the end of the tests. This was announced on Monday by Denis Logunov, Deputy Director of the Gamalei Center for Scientific Work, Corresponding Member of the Russian Academy of Sciences.
"You will be able to find out whether you are vaccinated or not only after donating blood at control points, <...> and only after that by determining the appropriate level of antibodies in the blood, if it is there, you will know. But in fact, the final result will be obtained only when the study is "sent out," that is, [when] the study is completed," he said at a conference on the Russian vaccine against the Sputnik V coronavirus.
Logunov also added that all clinical trials of vaccines in Russia take place in accordance with the Helsinki Declaration, so everything concerning serious adverse events is strictly regulated. "[In case of detection of undesirable phenomena in volunteers], we will have to report to the regulator within a day, and the regulator, after reviewing the expert council, will make a decision on suspending or not suspending the study, how long to suspend, how much to conduct in–depth proceedings, when to start after that," the scientist explained.
"We work with people, and the procedure for actions is clearly regulated here. If a serious undesirable phenomenon happens, you need to figure out very quickly whether it is related to the vaccine or not. If it is not connected, then the investigation continues, if it is connected, then an investigation takes place. Here in the Russian Federation we are no different from the EU countries, Latin America and the USA, the whole algorithm is clearly regulated," he said.
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